Senior Manager Contract Manufacturing - Purification

For 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to discover, develop, commercialize and manufacture biotherapeutics that address significant unmet medical needs. Today, Genentech manufactures and commercializes multiple biotechnology products that have helped patients suffering from serious diseases and conditions, including breast cancer, colorectal cancer, non-Hodgkin's lymphoma, lung cancer, rheumatoid arthritis, cystic fibrosis and allergic asthma. The company is the leading provider of anti-tumor therapeutics in the United States.

Our continued growth has created an opportunity for a Senior Manager of Contract Manufacturing in our South San Francisco headquarters. Please take this opportunity to learn about Genentech, where the creativity and openness of an academic environment meet the rigorous dedication of industry-leading professionals focused on improving and extending people?s lives.

Responsibilities:
The candidate will manage the Purification Technology Group in Manufacturing Collaborations Technology and ensure that purification technical support is provided to Bulk Contract Manufacturing Site Managers for on-going CMO operations as well as addressing critical issues and supporting key projects and opportunities. He/she will select and manage a group of two to three purification technical specialists for rotational assignments in MC Technology from Process Development or site Technology groups. The candidate will oversee CMO bulk site ongoing operation and provide purification technical support for these sites, as well as collaborate with bulk CMO sites in monitoring purification processes and performance. He/she will employ continuous improvement methodologies to troubleshoot and optimize CMO's purification operations and review and approve CMO?s manufacturing master batch records, recipes and SOPs. The candidate will support CMO projects, provide technical assessment of engineering P&IDs and functional requirements for new equipment or change orders and resolve manufacturing discrepancies and Quality investigations into process deviations. He/she will coordinate with other Genentech Manufacturing sites, other CMO sites and Process Development on operational best practices and process experiences. The candidate will provide support for new CMO selection process, including due-diligence if required. He/she will collaborate with Process Development and provide leadership and support on Technology Transfer, support CMO site preparation for audits and Regulatory Agencies Inspections and contribute to writing and review of Regulatory Submissions.

Requirements:
A B.S., M.S., or Ph.D. in Biology, Biochemistry, Chemistry, or Chemical Engineering and a minimum of five years of experience in a biotechnology purification manufacturing or process development environment is required. The candidate must have a minimum of five years of direct supervision experience with demonstrated leadership, collaboration and coaching abilities. A background in biotechnology manufacturing and/or purification technology with strong leadership and technical skills are required. Experience in technology transfer and the ability to build and lead an effective team of engineers and scientists supporting large scale manufacturing operations is required. Strong communication skills and the ability to collaborate with and influence a variety of groups, including CMO manufacturing and technical support teams, plus Genentech's Manufacturing Collaborations, Process Development, Corporate Engineering, Quality, Regulatory and Compliance organizations are essential.

Genentech offers one of the most comprehensive benefits packages in the industry. Join a company that attracts, retains and rewards talented and committed employees. Our culture emphasizes working hard, collaborating and sharing rewards. For immediate consideration, please visit www.gene.com/careers and reference Req. #1000013650. Genentech is an equal opportunity employer.